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The goal of this study is to evaluate whether textile-based electrodes can provide neurostimulation that is comparable in comfort and effectiveness to traditional hydrogel electrodes in healthy adults.
The main questions it aims to answer are:
Each participant will complete three stimulation conditions in random order across separate visits:
Electrical stimulation will be delivered to the lower leg muscles using a wearable sleeve with integrated electrodes. The investigators will assess sensorimotor thresholds (e.g., detection, motor, and full motor threshold), skin-electrode impedance, and torque. Participants will also rate stimulation comfort, intensity, and sensation location via questionnaire.
After the three primary arms, participants may optionally complete two additional arms using different moisturizers applied to the textile electrodes to evaluate their impact on stimulation performance.
The results of this study will help determine whether textile electrodes can be used as an effective and comfortable alternative to hydrogel electrodes in wearable neurostimulation applications.
Neurostimulation involves the use of electric current delivered through skin-surface electrodes to activate muscles. It is commonly used for purposes such as muscle strengthening, motor function improvement, blood flow enhancement, and in neuroprostheses. Standard neurostimulation systems typically rely on disposable hydrogel electrodes, which can cause skin irritation and tend to dry out over time. These limitations make hydrogel electrodes less suitable for long-term or repeated use.
Textile-based electrodes are an emerging alternative. These electrodes are integrated into wearable garments, making them washable, reusable, and more comfortable for extended wear times. However, research directly comparing their effectiveness and user experience compared to hydrogel electrodes is limited.
The goal of this study is to compare textile electrodes to gold-standard hydrogel electrodes for muscle activation and perceived stimulation sensation. The investigators hypothesize that: 1) there will be no clinically meaningful difference in participants' perception of the stimulation between textile and hydrogel electrodes, and 2) there will be no significant difference in the stimulation current required to elicit functional contractions.
This is a crossover randomized controlled trial involving three primary arms: 1) hydrogel electrodes, 2) dry polymer-textile electrodes with lotion, and 3) dry textile electrodes with gel pads applied. Each participant will perform all three arms in a randomized order with at least 24 hours between visits. Stimulation will be delivered to the calf and tibialis anterior muscles using the same electrical stimulator and settings in all conditions. Following completion of the three primary arms, participants will be given the option to complete an additional two arms using different types of commercially available moisturizers on the dry textile electrodes to assess comparative on-body performance of different water-based moisturizers. All moisturizers are commercially available and are labelled Skin Lotion A, B, and C in the 'Arms and Interventions' section.
A sample size of 18 participants is required to detect a Cohen's f of 0.40 with 95% power and a significance level of ⍺ = 0.05 for a within-subjects one-way repeated measures analysis of variance (ANOVA) with three conditions. To preserve statistical power, the investigators will recruit 20 participants. Pilot data comparing textile to hydrogel electrodes provided an estimated effect size of f = 0.65. Given the pilot data was not randomized, which likely inflated the observed effect size, the investigators conservatively based their sample size calculation on a Cohen's f of 0.40 (i.e., a large effect size) to ensure adequate power to detect a potentially smaller true effect.
A non-inferiority analysis will compare perceived stimulation intensity on a 10-point numerical rating scale. A 2-point difference is set as the non-inferiority margin based on prior research on the minimal clinically important difference. Textile electrodes will be considered non-inferior if the upper bound of the 95% confidence interval for the difference in intensity remains below this threshold. Repeated measures ANOVAs and Tukey's post hoc tests will be used to analyze the outcome variables where appropriate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrogel electrodes | Active Comparator | Gold-standard comparator |
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| Dry polymer-textile electrodes with Skin Lotion A | Experimental |
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| Dry textile electrodes with gel pads attached to the electrode | Experimental |
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| Dry polymer-textile electrodes with Skin Lotion B | Experimental |
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| Dry polymer-textile electrodes with Skin Lotion C | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogel electrodes | Device | Neurostimulation using standard self-adhesive hydrogel electrodes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived intensity of stimulation | Participants will rate the perceived intensity of electrical stimulation at the current required to elicit 20% of their maximal voluntary contraction (MVC). Intensity will be assessed using a 10-point numerical scale, where 0 represents no sensation and 10 represents painful stimulation. | At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensorimotor responses to electrical stimulation | Current amplitude required to elicit various sensorimotor responses will be recorded. Participants will receive electrical stimulation to the lower leg. The study will measure:
Stimulation will be increased gradually and stopped if discomfort is reported. All stimulation will not exceed safe current limits (i.e., 100 mA). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amirali Toossi | Contact | 4164237906 | amirali.toossi@myant.ca |
| Name | Affiliation | Role |
|---|---|---|
| Milad Alizadeh Meghrazi | Myant Medical Corp. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Myant Medical Corp | Mississauga | Ontario | L5K 2L1 | Canada |
Study is internal
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Crossover randomized controlled trial
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| Dry polymer-textile electrodes with Skin Lotion A | Device | Neurostimulation with dry polymer-textile electrodes using Skin Lotion A |
|
| Dry textile electrodes with gel pads attached to the electrode | Device | Neurostimulation with dry textile electrodes with gel pads attached to the electrode |
|
| Dry polymer-textile electrodes with Skin Lotion B | Device | Neurostimulation with dry polymer-textile electrodes with Skin Lotion B |
|
| Dry polymer-textile electrodes with Skin Lotion C | Device | Neurostimulation with dry polymer-textile electrodes using Skin Lotion C |
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| At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period. |
| Kinematic recruitment curves | Kinematic recruitment curves will be created by measuring ankle movement during stimulation. A camera will record the ankle as stimulation amplitude increases in small increments. Joint angles will be measured from the video and plotted against stimulation intensity to produce kinematic recruitment curves. | At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period. |
| Torque | Maximum voluntary contraction (MVC) will be determined through three maximal effort contractions of the ankle. Electrical stimulation will then be applied to determine the current required to produce 20% of the MVC. | At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period. |
| Sensation questionnaire | Participants will complete a questionnaire following stimulation to report:
| At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period. |
| Skin-electrode impedance | To measure electrical impedance, a small electrical signal will be sent through the electrodes across a range of frequencies, and resistance will be recorded. This helps evaluate how well the electrodes conduct current during use. | At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period. |